Status:
COMPLETED
Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment
Lead Sponsor:
Institut du Cancer de Montpellier - Val d'Aurelle
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-76 years
Phase:
PHASE3
Brief Summary
Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigu...
Detailed Description
Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigu...
Eligibility Criteria
Inclusion
- Female patient with histologically proven breast cancer
- 18-76 years old
- Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + taxanes) followed by radiotherapy
- Satisfactory healing of breast and lymph nodes area
- Ability to understand the nature, goal and study methodology
- Consent to cooperate for clinical assessments
- Affiliation to a social security regime or beneficiary of equivalent social protection
- Written informed consent provided before any study specific procedures
Exclusion
- HER2 positive or metastatic cancer
- Any other primary tumor
- Contraindication to moderate physical activity
- Contraindication to adjuvant chemotherapy or radiotherapy
- Pregnancy or breast feeding
- Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01495650
Start Date
December 1 2010
End Date
December 1 2014
Last Update
August 21 2017
Active Locations (1)
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1
CRLC Val d'Aurelle-Paul Lamarque
Montpellier, France, 34298